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FDA 510(k)

MONOLISA ANTI-HAV IGM EIA

K-Number: K092353 · 2009-10-29

ApplicantBio-Rad Laboratories, Inc.
Decision Date2009-10-29
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MONOLISA ANTI-HAV IGM EIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2009-10-29 under 510(k) number K092353. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOLISA ANTI-HAV IGM EIA?

MONOLISA ANTI-HAV IGM EIA is a medical device that received FDA 510(k) clearance on 2009-10-29. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K092353.

When did MONOLISA ANTI-HAV IGM EIA receive FDA 510(k) clearance?

MONOLISA ANTI-HAV IGM EIA received FDA 510(k) clearance on 2009-10-29, under 510(k) number K092353.

Who is the listed applicant for MONOLISA ANTI-HAV IGM EIA?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOLISA ANTI-HAV IGM EIA?

The FDA product code for MONOLISA ANTI-HAV IGM EIA is LOL.

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Related Devices (Code: LOL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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